STA-CEPHASCREEN KIT— 510(k) K053111
Substantially EquivalentDiagnostica Stago, Inc.
FDA 510(k) clearance K053111 for STA-CEPHASCREEN KIT, Substantially Equivalent on 2006-05-04. Applicant: Diagnostica Stago, Inc.. Device class: 2.
Clearance details
- Applicant
- Diagnostica Stago, Inc.
- Product code
- Code GFO
- Device class
- Class 2
- Regulation
- 21 CFR 864.7925
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Parisppany, NJ, US
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